This invention relates to a device for occluding a hole existing in a body wall, insertable by mini-invasive non chirurgical route, i.e. going through body ducts. The invention also relates to a unit for inserting said device.
The invention is applicable in particular to the occlusion of septal defects between the right-hand auricle and the left-hand auricle or between the right-hand ventricle and the left-hand ventricle of a heart.
Closing such septal defects is performed usually by surgical intervention or by using a cardiac catheter running through the vessels, wherein deployable occlusion devices are placed.
The document U.S. Pat. No. 5,846,261 A describes one of these devices, composed of two voluminous and rigid disks, wider than the communication to be closed, and of an inter-disk portion of the size of the communication to be sealed. The implantation is visualised thanks to X-rays on two-dimensional imaging screen. The device is loaded in the catheter, then is brought forward into the left-hand auricle through the interauricular communication; the first disk is then extracted from the catheter and is applied to the interauricular septum, thereby occluding the communication; the second disk is then extracted from the catheter and sandwiches the interauricular septum closing the communication.
Although simple, the use of such devices is limited to the treatment of holes or of communications present in tissular walls with a certain bank width, equal to or greater than 7 millimetres, and not exceeding a certain size. Moreover, the rigidity of the device described by the previous document makes it unusable in young children.
There results that numerous interauricular communications are closed by surgical route, with direct control of the communication to be treated. This surgery involves opening the thorax and implementing extracorporeal circulation to empty the blood from the heart and enable stitching up the septal defect. In case of large size communication, a pericardium or PTFE patch is necessary for the occlusion.
The document EP 1,046,375 A1 describes a similar device, with two disks connected together. These disks have a diameter slightly greater than the diameter of the communication to be treated and are connected by an elastic thread, which thread enabling, after implantation, to maintain the disks pressed against the respective faces of the body wall treated.
The purpose of the present invention is to provide a device which is easier to insert than that according to this previous document, with smaller space requirements, and held more securely onto said body wall.
The document WO 01/30267 describes devices for closing or excluding a cavity, comprising an occlusion disk and a structure for anchoring said disk to the body walls forming said cavity.
The device according to this document is not suited to the occlusion of a hole or communication existing in a body wall, in particular in the interauricular septum of a heart, by very little invasive route.